Business Overview
Dare Bioscience, Inc. is a biopharmaceutical company dedicated to advancing innovative products for women’s health. The company has assembled a diverse portfolio of product candidates targeting unmet needs in areas such as contraception, sexual health, pelvic pain, fertility, infectious disease, and menopause. Dare Bioscience’s commitment to women’s well-being and its focus on bringing disruptive treatments to market have positioned it as a leader in the women’s health pharmaceutical space.
Dare Bioscience was founded in 2017 with the mission of identifying, developing, and commercializing differentiated therapies that prioritize women’s health and well-being. The company’s strategy involves in-licensing or acquiring the rights to promising product candidates, many of which have existing clinical proof-of-concept data, and then advancing them through mid to late-stage clinical development and regulatory approval.
Since its inception, Dare’s primary operations have consisted of research and development activities to advance its product candidates through clinical development and regulatory approval. The company’s first FDA-approved product, XACIATO (clindamycin phosphate vaginal gel 2%), received approval in December 2021 for the treatment of bacterial vaginosis in females 12 years of age and older. In March 2022, Dare entered into an agreement with an Organon affiliate, Organon International GmbH, to commercialize XACIATO worldwide, which became fully effective in June 2022.
In 2019, Dare acquired Dare MB Inc. to secure the rights to develop a long-acting reversible contraception method, now known as DARE-LARC1. Under the terms of the merger agreement, Dare agreed to pay former MBI stockholders up to $46.5 million in contingent payments upon the achievement of specified milestones. In June 2021, a total of $1.25 million of these contingent consideration payments became payable.
Dare has received substantial non-dilutive funding to support the development of its product candidates. In June 2021, the company entered into an agreement with the Bill & Melinda Gates Foundation under which it was awarded up to $49 million to support the development of DARE-LARC1. As of September 30, 2024, Dare had received a cumulative total of approximately $29.3 million in funding under this agreement.
Dare Bioscience’s portfolio includes five product candidates in advanced clinical development, ranging from Phase 2-ready to Phase 3. These include Ovaprene, a hormone-free monthly intravaginal contraceptive; Sildenafil Cream, 3.6%, a proprietary cream formulation of sildenafil for the treatment of female sexual arousal disorder (FSAD); DARE-HRT1, an intravaginal ring designed to deliver bioidentical estradiol and progesterone for the treatment of moderate-to-severe vasomotor symptoms associated with menopause; DARE-VVA1, a proprietary formulation of tamoxifen for intravaginal administration as a hormone-free alternative for the treatment of moderate-to-severe dyspareunia; and DARE-HPV, a proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of human papillomavirus (HPV)-related cervical diseases.
The company also has five product candidates in Phase 1 clinical development or that are Phase 1-ready, including DARE-PDM1, DARE-204, DARE-214, DARE-FRT1, and DARE-PTB1. Additionally, Dare Bioscience has five preclinical stage programs, including DARE-LARC1, DARE-LBT, DARE-GML, DARE-RH1, and DARE-PTB2.
Financials
Dare Bioscience reported net revenue of $0.07 million for the nine months ended September 30, 2024, compared to $1.00 million for the same period in 2023. The decrease in revenue was primarily due to the company’s sale of its rights to future royalty and milestone payments from Organon related to the commercialization of XACIATO, the company’s first FDA-approved product, in April 2024.
For the nine months ended September 30, 2024, Dare Bioscience reported a net income of $1.45 million, compared to a net loss of $25.10 million for the same period in 2023. This significant improvement in financial performance was largely attributable to the $20.38 million in net proceeds the company received from the sale of its royalty and milestone rights to XOMA.
As of September 30, 2024, Dare Bioscience had $11.23 million in cash and cash equivalents, compared to $10.48 million as of December 31, 2023. The company’s working capital was $1.80 million as of September 30, 2024.
It’s important to note that Dare Bioscience’s cash and cash equivalents balance as of September 30, 2024 includes grant funds received under agreements that may only be applied toward direct costs for the development of specific product candidates, such as DARE-LARC1 and the company’s bacteria-based live biotherapeutic product. Approximately $10.00 of these grant funds may be applied toward general overhead and administration expenses that support the entire operations of the company.
For the most recent quarter (Q3 2024), Dare Bioscience reported revenue of $41,691, a net loss of $4,702,501, operating cash flow of -$6,820,636, and free cash flow of -$6,827,932. The decrease in revenue, net income, operating cash flow, and free cash flow compared to the prior year quarter was primarily due to increased R&D expenses related to the ongoing clinical trials for Ovaprene and Sildenafil Cream.
As of September 30, 2024, Dare Bioscience’s current ratio and quick ratio were both 1.14, indicating that the company has sufficient short-term assets to cover its short-term liabilities.
Liquidity
Based on the company’s current operating plan estimates, Dare Bioscience does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying condensed consolidated financial statements. The company will need to raise substantial additional capital to continue to fund its operations and successfully execute its current strategy.
To address its liquidity needs, Dare Bioscience has secured several sources of non-dilutive funding in recent months. These include a $10 million award from ARPA-H for the DARE-HPV program, a $10.7 million grant from the Bill & Melinda Gates Foundation to support the Ovaprene clinical trial and development of a novel non-hormonal intravaginal contraceptive, a $15 million equity line arrangement with Lincoln Park Capital, and $22 million in non-dilutive strategic royalty financing secured in Q2 2024.
Recent Developments and Milestones
In the past year, Dare Bioscience has achieved several important milestones and secured significant non-dilutive funding to advance its pipeline:
Ovaprene Pivotal Study: In December 2023, Dare Bioscience commenced the patient enrollment in the pivotal Phase 3 clinical study of Ovaprene, its novel hormone-free monthly intravaginal contraceptive candidate. The study is being conducted under a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and within NICHD’s Contraceptive Clinical Trial Network.
Sildenafil Cream, 3.6% Development: Dare Bioscience continued its constructive interactions with the FDA regarding the development program for Sildenafil Cream, 3.6%, its investigational topical cream formulation of sildenafil for the treatment of female sexual arousal disorder (FSAD). The company is aligning with the FDA on key elements of the Phase 3 program, including the clinical trial design and efficacy endpoints.
DARE-HPV Program Advancement: In October 2024, Dare Bioscience was selected by the Advanced Research Projects Agency for Health (ARPA-H) as an awardee of the Sprint for Women’s Health. The company will receive $10 million in funding over two years to advance the development of DARE-HPV, its proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of human papillomavirus (HPV)-related cervical diseases.
Non-Dilutive Funding Secured: In the past 30 days, Dare Bioscience has secured over $20 million in non-dilutive funding, including a $10.7 million grant from the Bill & Melinda Gates Foundation and the $10 million ARPA-H award. These funds will support the expansion of the Ovaprene pivotal study and the advancement of the DARE-HPV program, as well as the identification and development of a novel non-hormonal intravaginal contraceptive candidate.
Risks and Challenges
Dare Bioscience faces several risks and challenges common to the biopharmaceutical industry, including:
Clinical development and regulatory approval: The process of developing and obtaining regulatory approvals for Dare Bioscience’s product candidates is inherently uncertain and requires significant financial resources, with no guarantee of success.
Commercialization and market acceptance: Even if Dare Bioscience’s product candidates receive regulatory approvals, the company may face challenges in successfully commercializing them and achieving market acceptance.
Intellectual property protection: The company’s ability to protect its intellectual property rights and in-licensed technologies is critical to its success.
Reliance on third-party collaborators: Dare Bioscience’s partnerships with companies like Organon and Bayer are essential to the development and commercialization of its product candidates, but the company has limited control over the resources and priorities of its collaborators.
Outlook and Conclusion
Dare Bioscience is well-positioned to continue advancing its diverse portfolio of potentially disruptive women’s health product candidates. The company’s recent success in securing significant non-dilutive funding, including grants from the Bill & Melinda Gates Foundation and ARPA-H, demonstrates the external validation and support for its innovative approach to addressing unmet needs in women’s health.
With multiple late-stage clinical programs progressing, including the pivotal Phase 3 study of Ovaprene and the planned Phase 3 development of Sildenafil Cream, 3.6%, Dare Bioscience is poised to deliver meaningful milestones in the coming years. Additionally, the advancement of earlier-stage candidates, such as DARE-HPV, DARE-VVA1, and DARE-PTB1, further bolsters the company’s long-term pipeline.
While Dare Bioscience faces the common challenges of the biopharmaceutical industry, including the need to raise additional capital, the company’s laser focus on women’s health, its robust portfolio, and its ability to secure non-dilutive funding position it as a leader in the development of innovative treatments that can improve the lives of women worldwide.
Looking ahead, Dare Bioscience has indicated that its R&D expenses for the full year 2024 are expected to be less than its 2023 R&D expenses. The company has not provided specific numerical guidance for future financial metrics but has highlighted several upcoming milestones planned for 2025 based on the recent non-dilutive funding received. These milestones, coupled with the progress in its clinical programs, suggest a potentially promising future for Dare Bioscience as it continues to advance its mission of improving women’s health through innovation.
Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.